Beneficiary: University Hospital Jena - Department of Internal Medicine III - Functional Area Nephrology
Funding exploratory phase: 01.07.2013 bis 31.07.2014; 49.317 Euro

Project description

Each year about 226 people per 100,000 inhabitants suffer from sepsis. The overall hospital mortality rate for severe sepsis in Germany is 54%. In intensive care, sepsis is the leading cause of death. The intensive medical treatment costs for sepsis in Germany amount to 1.77 billion euros per year; the follow-up costs total 4.52 billion euros.

The high mortality rate and the high costs are caused by the low sensitivity and specificity of previous sepsis diagnoses. Therefore, a suitable diagnostic test for sepsis is being developed worldwide.

The assay to be developed in this project is a cell-based in vitro test system for the diagnosis of sepsis-associated markers from body fluids such as blood. For diagnostic purposes, patient blood is collected and then injected into a cell suspension on site or in the laboratory.

The realization of the assay was investigated in four work packages: work package 1 included the preparation of the "freedom to operate" analysis, in work package 2, market environment analyses and market opportunity analyses were carried out and finally evaluated.

Work package 3 dealt with regulatory aspects, e.g. research on the legal framework of a marketing authorisation. Work package 4 included analyses on technical feasibility, requirements according to the Genetic Engineering Act as well as the evaluation of the results.

These analyses have shown that the marketing of the diagnostic essay requires a spin-off and an external partner for the provision of expertise and finances.